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DV3395 C1

Phase 1

Healthy Volunteers, Medical Device | Unknown | Other |Novo Nordisk A/S|Last Updated: Nov 19, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

DV3395 C1 · 1 trial · 1 indication

Phase 1 1
NCT05314283A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine.Healthy Volunteers, Medical Device
COMPLETED65 Analytics
PHASE1COMPLETED
A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine.
Healthy Volunteers, Medical Device
NCT0531428365
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Study Endpoints

Primary Endpoints

Number of adverse events
From exposure (defined as when the participant takes DV3395-C1 into his/her hand with the intention of swallowing it) to DV3395 C1 on day 1 (visit 2) to 7 days after excretion of DV3395 C1 (phone visit 3, expected between day 9 and day 12)

Number of events

Secondary Endpoints

Confirmed DV3395 C1 integrity upon excretion (yes/no)
On day of excretion of DV3395 C1 (visit 2, expected between day 2 and day 5)
Confirmed gastric activation of DV3395 C1 (yes/no)
From administration (defined as when the participant places DV3395-C1 in his/her mouth with the intention of swallowing it) of DV3395 C1 on day 1 (visit 2) to time of last image approximately 5 hours later on day 1 (visit 2)
Time to activation of DV3395 C1
From administration (defined as when the participant places DV3395-C1 in his/her mouth with the intention of swallowing it) of DV3395 C1 on day 1 (visit 2) to time of last image approximately 5 hours later on day 1 (visit 2)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
DV3395 C1EXPERIMENTAL -

Interventions

NameTypeDescription
DV3395 C1DEVICEParticipants will be exposed to and swallow DV3395 C1 once. The participants will stay at the clinic research center for up to 6 days .
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. * Body mass index between 18.5 and 29.9 k...

Countries:Netherlands
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Frequently asked questions about DV3395 C1

What is DV3395 C1 used for?

DV3395 C1 is an investigational medical device being studied for the delivery of medicine in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety and performance. The device is intended for use in medical device applications, though it is not yet approved for any specific medical condition.

Who makes DV3395 C1?

DV3395 C1 is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVO. The company is conducting clinical research to evaluate the safety and performance of this new concept device for medicine delivery.

What phase is DV3395 C1 in?

DV3395 C1 is in Phase 1 clinical development. A single Phase 1 trial has been completed, which enrolled 65 healthy volunteers in the Netherlands. The study was uncontrolled and not randomized or double-blinded, reflecting its early-stage evaluation of the device's safety and performance.

What clinical trials is DV3395 C1 in?

DV3395 C1 has one completed clinical trial registered under NCT05314283, titled "A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine." This Phase 1 study enrolled 65 healthy volunteers aged 18 years and older in the Netherlands.

Is DV3395 C1 FDA approved?

DV3395 C1 is not FDA approved. It is an investigational medical device currently in Phase 1 clinical development. The completed trial focused on safety and performance in healthy volunteers, and the device has not yet received regulatory approval for any medical use.